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fda_recall · device_recall · critical

Datex-Ohmeda Inc — Class I recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (r…

Event date
2026-06-24 00:00:00Z
Observed
2026-07-09 22:52:02Z
Source ID
Z-2357-2026
Payload hash
c3a190121381e57f871db1eb…

Summary

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Datex-Ohmeda Inc had other FDA enforcement actions?
Yes. Argus HQ has recorded 7 total FDA actions tied to Datex-Ohmeda Inc: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2026-06-24; Argus observed and indexed it on 2026-07-09.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Datex-Ohmeda Inc — Class I recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (r…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-datex-ohmeda-inc-z-2357-2026
MLA
"Datex-Ohmeda Inc — Class I recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (r…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-datex-ohmeda-inc-z-2357-2026.
Chicago
Argus HQ Research. "Datex-Ohmeda Inc — Class I recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (r…." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-datex-ohmeda-inc-z-2357-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_datex_ohmeda_inc_z_2357_2026_2026,
  title = {Datex-Ohmeda Inc — Class I recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (r…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-datex-ohmeda-inc-z-2357-2026},
  note = {Accessed: September 29, 2026}
}

Informational only. Not legal, financial, or medical advice.

Datex-Ohmeda Inc — Class I recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (r… · Argus HQ